Perineorrhaphy Outcomes Related to Body Imagery
Status: | Completed |
---|---|
Conditions: | Women's Studies |
Therapuetic Areas: | Reproductive |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/6/2019 |
Start Date: | August 2015 |
End Date: | May 1, 2017 |
Perineorrhaphy Outcomes Related to Body Imagery (POETRY)
The purpose of this study is to determine whether performing a perineorrhaphy during a
reconstructive surgery indicated for pelvic organ prolapse (POP) affects a patient's body
image.
reconstructive surgery indicated for pelvic organ prolapse (POP) affects a patient's body
image.
The objective of this study is to assess the body image of women before and after pelvic
reconstructive surgery with and without perineorrhaphy to examine if a perineorrhaphy impacts
postoperative body image by conducting a single-blind, randomized controlled clinical trial.
The central hypothesis is that patients' body image will not be affected by whether or not a
perineorrhaphy is performed.
The target population are those patients with POP who are planning an apical prolapse repair.
All participants will give written consent prior to their surgery. After enrollment, women
will fill out baseline surveys, including the Body Image in Pelvic Organ Prolapse (BIPOP),
the Pelvic organ prolapse/Incontinence Sexual Questionnaire, IUGA-revised) (PISQ-IR), the
Pelvic Floor Distress Inventory (PFDI-20), and a Pain Visual Analog Scale (VAS) to assess
baseline pain. Additionally, participants will undergo a Pelvic Organ Prolapse Quantification
(POP-Q) examination with the addition of measurements of genital hiatus (GH) and perineal
body (PB) lengths without strain. The other measurements involved in the POP-Q entail
assigning numerical values to descent of different parts of the vagina. Pelvic floor muscle
strength will be measured using a Peritron™ perineometer and Kegel strength (contraction of
the pelvic floor muscles) using the Oxford grading scale.
On the day of the patient's surgery, the surgeon will call a research coordinator who will
open the next envelope in the sequence randomizing the patient to perinorrhaphy or to no
perineorrhaphy. Randomization assignment will be generated by a computer-based randomization
table and assigned by a research coordinator not otherwise involved in the study. Women will
not be informed to what arm of the study they were randomized, and postoperative assessments
will be made by individuals not involved with the patient's surgery.
At prescribed time points post-operatively, the patients will be assessed by POP-Q, genital
hiatus and perineal body measurements performed with and without strain, the pain VAS, the
BIPOP, The PISQ-IR, the PFDI-20, and pelvic floor muscle strength via the Oxford scale and
measurement by the Peritron™ perineometer.
The investigators' aims for this study are:
Aim #1: To determine if a patient's body image, by using the Body Image in Pelvic Organ
Prolapse (BIPOP) questionnaire, is affected by concomitant performance of a perineorrhaphy at
the time of pelvic organ prolapse surgery. Hypothesis: There will be no difference in body
image scores between those with and without concomitant perineorrhaphy.
Aim #2: To determine if Pelvic Organ Prolapse Quantification (POP-Q) measurements are
affected by a perineorrhaphy. Hypothesis: After a perineorrhaphy, the genital hiatus (GH)
will be smaller, the total vaginal length (TVL) will be longer, the perineal body (PB) will
be longer, and all others will be unaffected when compared to those in whom perineorrhaphy is
not performed.
Aim #3: To determine if the strength of pelvic floor muscles is improved after corrective
pelvic organ prolapse surgery with a perineorrhaphy compared with those patients who did not
have a perineorrhaphy, as measured by the Peritron™, a perineometer device that measures
pelvic floor muscle contraction strength. Hypothesis: Pelvic floor muscle strength will be
unaffected by the performance of a perineorrhaphy.
Aim #4: To assess if those having a perineorrhaphy have higher postoperative pain both in the
short term and long term by using a visual analog scale (VAS) both in the immediate and 6
week postoperative period. Hypothesis: Those with perineorrhaphies will report more pain on a
VAS both immediately and 6 weeks post-surgery.
Aim #5: To describe if there are differences in sexual function after corrective pelvic organ
prolapse with a perineorrhaphy compared to those who did not undergo a perineorrhaphy.
Hypothesis: Sexual function will be improved after POP surgery repair but will be unaffected
by the performance of a perineorrhaphy.
reconstructive surgery with and without perineorrhaphy to examine if a perineorrhaphy impacts
postoperative body image by conducting a single-blind, randomized controlled clinical trial.
The central hypothesis is that patients' body image will not be affected by whether or not a
perineorrhaphy is performed.
The target population are those patients with POP who are planning an apical prolapse repair.
All participants will give written consent prior to their surgery. After enrollment, women
will fill out baseline surveys, including the Body Image in Pelvic Organ Prolapse (BIPOP),
the Pelvic organ prolapse/Incontinence Sexual Questionnaire, IUGA-revised) (PISQ-IR), the
Pelvic Floor Distress Inventory (PFDI-20), and a Pain Visual Analog Scale (VAS) to assess
baseline pain. Additionally, participants will undergo a Pelvic Organ Prolapse Quantification
(POP-Q) examination with the addition of measurements of genital hiatus (GH) and perineal
body (PB) lengths without strain. The other measurements involved in the POP-Q entail
assigning numerical values to descent of different parts of the vagina. Pelvic floor muscle
strength will be measured using a Peritron™ perineometer and Kegel strength (contraction of
the pelvic floor muscles) using the Oxford grading scale.
On the day of the patient's surgery, the surgeon will call a research coordinator who will
open the next envelope in the sequence randomizing the patient to perinorrhaphy or to no
perineorrhaphy. Randomization assignment will be generated by a computer-based randomization
table and assigned by a research coordinator not otherwise involved in the study. Women will
not be informed to what arm of the study they were randomized, and postoperative assessments
will be made by individuals not involved with the patient's surgery.
At prescribed time points post-operatively, the patients will be assessed by POP-Q, genital
hiatus and perineal body measurements performed with and without strain, the pain VAS, the
BIPOP, The PISQ-IR, the PFDI-20, and pelvic floor muscle strength via the Oxford scale and
measurement by the Peritron™ perineometer.
The investigators' aims for this study are:
Aim #1: To determine if a patient's body image, by using the Body Image in Pelvic Organ
Prolapse (BIPOP) questionnaire, is affected by concomitant performance of a perineorrhaphy at
the time of pelvic organ prolapse surgery. Hypothesis: There will be no difference in body
image scores between those with and without concomitant perineorrhaphy.
Aim #2: To determine if Pelvic Organ Prolapse Quantification (POP-Q) measurements are
affected by a perineorrhaphy. Hypothesis: After a perineorrhaphy, the genital hiatus (GH)
will be smaller, the total vaginal length (TVL) will be longer, the perineal body (PB) will
be longer, and all others will be unaffected when compared to those in whom perineorrhaphy is
not performed.
Aim #3: To determine if the strength of pelvic floor muscles is improved after corrective
pelvic organ prolapse surgery with a perineorrhaphy compared with those patients who did not
have a perineorrhaphy, as measured by the Peritron™, a perineometer device that measures
pelvic floor muscle contraction strength. Hypothesis: Pelvic floor muscle strength will be
unaffected by the performance of a perineorrhaphy.
Aim #4: To assess if those having a perineorrhaphy have higher postoperative pain both in the
short term and long term by using a visual analog scale (VAS) both in the immediate and 6
week postoperative period. Hypothesis: Those with perineorrhaphies will report more pain on a
VAS both immediately and 6 weeks post-surgery.
Aim #5: To describe if there are differences in sexual function after corrective pelvic organ
prolapse with a perineorrhaphy compared to those who did not undergo a perineorrhaphy.
Hypothesis: Sexual function will be improved after POP surgery repair but will be unaffected
by the performance of a perineorrhaphy.
Inclusion Criteria:
- Subjects ≥ 18 years of age
- Symptomatic POP who desire vaginal or abdominal apical suspension
- English-speaking/reading
- Genital hiatus measurement < 6 cm, >2cm
Exclusion Criteria:
- Those who desire colpocleisis
- Those whose surgical planning includes levatorplasty
- Genital hiatus measurements greater than or equal to 6 cm, < 2 cm
- Inability to speak/understand English
- Those who specifically request a perineorrhaphy
- Pregnant patients
We found this trial at
2
sites
Albuquerque, New Mexico 87131
(505) 277-0111
Principal Investigator: Cara S Ninivaggio, MD
Phone: 505-272-9712
University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
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